Healthy Skepticism Library item: 5751
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Day M, Hawkes N.
Slimming wonder drugs could be a danger for mothers-to-be
Times Online 2006 Aug 2
http://www.timesonline.co.uk/printFriendly/0,,1-2-2295507-2,00.html
Notes:
Ralph Faggotter’s Comments:
“ In trials involving more than 6,000 patients in the US and Europe, about a quarter of those taking it lost more than 10 per cent of their weight after a year.”
This sounds impressive, but remember that the results of weight-loss drug trials will always be better than results in the real world due to the special conditions which exist in a trial. The patients as regularly weighed and monitored and urged to keep on the recommended diet etc.
Unfortunately this amount of personal attention does not come with a regular prescription.
Furthermore- what happens when the medication is stopped?
This is a critical question, since most weight-loss drugs are very expensive with long-term side efects and therefore are not taken for too long. More often than not, the sujbect regains all the weight they lost within a short time because they have not made any genuine conscious improvements in their life-style.
Full text:
The Times August 02, 2006
Slimming wonder drugs could be a danger for mothers-to-be
By Michael Day and Nigel Hawkes
WOMEN of childbearing age may be at risk from using rimonabant, the latest weight-loss “wonder drug”, leading scientists have said.
The alert comes after evidence that a key chemical that is affected by the drug is needed for embryos to implant normally in the womb. It is feared that even small variations in the level of anandamide, which governs the development and implantation of the embryo, could have disastrous consequences.
The weight-loss pill was introduced in Britain under the brand name Acomplia this summer as a drug that can help a person to lose 10 per cent of their weight in a year. It works by interacting with anandamide to reduce appetite and, it has also been claimed, helps smokers to give up by reducing their cravings.
Test results for rimonabant were quite impressive. In trials involving more than 6,000 patients in the US and Europe, about a quarter of those taking it lost more than 10 per cent of their weight after a year.
But research sponsored by the US Government and published in the The Journal of Clinical Investigation suggests that the drug may also be able to alter levels of anandamide. Experiments with mice have shown catastrophic effects on the development of embryos.
The researchers believe that potential adverse effects could include ectopic pregnancy – in which an embryo fails to move to the womb for correct implantation. This could occur very early in pregnancy, possibly before a woman even knew she had conceived.
Sudhansu Dey, director of reproductive and developmental biology at Vanderbilt University Medical Centre, Nashville, said that his work raised real concerns about the safety of rimonabant in women of child-bearing age.
For example, women might use the drug in the hope that it would help them to quit smoking before they conceived, not realising the potential risks.
Professor Dey said that he had spoken to the manufacturer of rimonabant, the French drug company Sanofi-Aventis, about his concerns. “I gave a talk to them to explain the problems, but I didn’t hear from them again,” he said. “At least they should consider putting a warning on the packets.”
The potential market is huge. Some analysts have predicted that Acomplia alone could generate worldwide sales in excess of £3 billion. The drug was given official European Union marketing approval in June. Sanofi-Aventis also hopes to win a licence in the US, where the Food and Drug Administration has asked for more information.
Herbert Schuel, an expert in reproductive biology at the State University of New York, in Buffalo, said: “Given the results presented by Professor Dey’s study, we need to be very sure that rimonabant doesn’t have unwanted effects on women of reproductive age.”
A spokeswoman for Sanofi-Aventis said that existing packages advised women who were pregnant to consult their GP before continuing with medication. “Sanofi-Aventis takes the safety of all its medicines seriously and will report any adverse events to regulatory authorities,” she said. “We do not recommend the use of rimonabant during pregnancy.”
The study does not address the effects of rimonabant directly but looks at marijuana, which also affects levels of anandamide. Professor Dey’s team showed that very precise levels were required for healthy pregnancies in mice.
THE DANGER
- Ectopic pregnancies are one of the most dangerous complications faced by women expecting babies
- They occur when an egg fertilised in the Fallopian tubes fails to reach the womb
- The embryo can implant in the Fallopian tubes, ovaries, abdomen or cervix
- Anything that slows the movement of the egg can increase the risk. Research suggests that Acomplia may have that effect
- Ectopic pregnancies, which are becoming more common, can cause rupturing of the Fallopian tubes and internal bleeding and kill the mother
- A woman who has had an ectopic pregnancy is more likely to have another, and her fertility is likely to be reduced
